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Patients who have undergone coronary bypass surgery have had a vein removed from the leg and implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils that keep the artery open). Two types of stents are currently used: bare metal stents (BMS) and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a drug that releases into the wall of the blood vessel to prevent scar tissue from forming and re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS and DES are routinely being used in SVGs, but it is not known which one is better. Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs.

In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical reason for needing the medication. Patients without ACS who receive DES also need to take 12 months of a thienopyridine whether or not they are in the study, but non-ACS patients who receive a BMS do not. In order to make sure patients do not know which stent they received, non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed by 11 months of blinded placebo, while those who received DES will receive 1 month of open label thienopyridine followed by 11 months of blinded clopidogrel, which is a thienopyridine.

All study patients will be followed in the clinic for at least 1 year after their stenting procedure to see if there is a difference in the rate of cardiac death, heart attack, or any procedure that is required in order to increase the flow of blood to and from the heart between the BMS and DES groups.

Patients receive one or more bare metal stents in the saphenous vein graft target lesion.

Other Name: BMS

Drug: Placebo

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.

Drug: Thienopyridine (open-label)

For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Experimental: DES Group

Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).

Device: Drug-Eluting Stent

Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.

Other Name: DES

Drug: Blinded clopidogrel

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.

Other Name: Plavix

Drug: Thienopyridine (open-label)

For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Number of Participants With Target Vessel Failure (TVF), Which Will be Defined as the Composite of Cardiac Death, Target Vessel Myocardial Infarction and Target Vessel Revascularization. [ Time Frame: 12 months ]

Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established. [ Time Frame: 12 months ]

Number of Participants With Myocardial Infarction (MI) After Discharge From the Initial Stenting Procedure. [ Time Frame: 12 months ]

Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition [ Time Frame: 12 months ]

Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.

Angiographic Confirmation of Stent Thrombosis will be defined as the presence of thrombus originating in a study stent, or in the segment 5mm proximal or distal to the stent AND fulfillment of at least one of the following 5 criteria within a 48 hour time window:

Acute onset of ischemic symptoms at rest

New ischemic ECG changes suggestive of acute ischemia

Rise and fall of cardiac biomarkers

Nonocclusive intracoronary thrombus seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream

Occlusive intracoronary thrombus Pathological Confirmation of stent thrombosis will be defined as evidence of recent thrombus with the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.

Patient-oriented and Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement. [ Time Frame: 12 months ]

Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided. [ Time Frame: 12 months ]

Number of Participants With Any Revascularization [ Time Frame: 12 months ]

Number of Participants With Definite or Probable Stent Thrombosis [ Time Frame: 12 months ]

Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.

Probable Stent Thrombosis will clinically be considered to have occurred after index Saphenous Vein aortocoronary bypass Graft (SVG) stenting (the Percutaneous Coronary Intervention (PCI) immediately after randomization) in the following cases: a) any unexplained death within the first 30 days OR b) Irrespective of the time after the index procedure, any MI which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age 18 years

Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.25 and 4.5 mm in diameter and that is considered to cause clinical or functional ischemia

Intent to use a distal embolic protection device

Agrees to participate and to take prescribed medications as instructed

Has provided informed consent and agrees to participate

Exclusion Criteria:

Planned non-cardiac surgery within the following 12 months

Presentation with an ST-segment elevation acute myocardial infarction

Target SVG is the last remaining vessel or is the "left main" equivalent

Allergy to clopidogrel in patients who do not present with an acute coronary syndrome (ACS), where ACS is defined as cardiac ischemic symptoms occurring at rest and 1 of the following 3 criteria: electrocardiographic changes suggestive of ischemia (ST-segment elevation or depression 1 mm in 2 contiguous leads, or new left bundle branch block, or posterior myocardial infarction); positive biomarker indicating myocardial necrosis (troponin I or T or creatine kinase-MB greater than the upper limit of normal); or coronary revascularization performed during hospitalization triggered by the cardiac ischemic symptoms

Participating in another interventional randomized trial (required condition for all CSP studies) for which dual enrollment with DIVA is not approved